救回“幾乎被放棄”的分子，藥明康德噴霧干燥技術(shù)與能力的背后 | 專訪陳金玲博士 | Bilingual

2026年5月，在藥明康德位于瑞士的庫威基地（Couvet Site），一場別開生面的“開放日”活動正在舉行。

在這座位于歐洲腹地的研發(fā)生產(chǎn)基地中，來自全球的客戶與合作伙伴穿梭于高度自動化的制劑生產(chǎn)產(chǎn)線之間，而對許多人來說，最吸引他們的目光的，是那座高達六層樓、通體銀白的巨型設(shè)備——PSD-4噴霧干燥設(shè)施。

藥明康德高級副總裁、制劑研發(fā)和生產(chǎn)業(yè)務(wù)部負責人陳金玲博士正參與其中，為來自全球的合作伙伴介紹新落成的噴霧干燥車間，以及即將于今年四季度投產(chǎn)的全新噴霧干燥設(shè)備。

故事的開端，往往始于一個看似無解的難題。

幾年前，藥明康德接手了一個復雜的新藥開發(fā)項目，該分子的分子量超過1000道爾頓，水溶性低，口服吸收率低于1%，幾乎被判定為“不具備繼續(xù)開發(fā)價值”。

這類分子是當下抗癌新藥研發(fā)領(lǐng)域的前沿方向之一的蛋白降解靶向嵌合體，在靶向“不可成藥”的蛋白靶點方面具有多重優(yōu)勢。然而，其高分子量以及復雜的化學結(jié)構(gòu)也為其開發(fā)帶來了極大的挑戰(zhàn)——溶解度差、口服生物利用度低。

當客戶找到藥明康德，陳金玲博士和她的團隊沒有輕易放棄。“通過與客戶的緊密合作，團隊探索了多種提高化合物生物利用度的藥物遞送方法，最終發(fā)現(xiàn)噴霧干燥最為有效。”她回憶道。經(jīng)過審慎的噴霧干燥和制劑處方篩選、配方優(yōu)化以及工藝流程調(diào)整，團隊成功將該化合物的生物利用度提高到30%以上。

30%，這個數(shù)字不僅僅是實驗室里的一行數(shù)據(jù)，它意味著一個原本要被束之高閣的化合物，那個原本“幾乎被放棄”的分子，重新獲得了繼續(xù)進入臨床開發(fā)以及走向患者的“入場券”。

因為一項關(guān)鍵技術(shù)的賦能，讓希望重燃。這個故事，正是藥明康德在庫威基地持續(xù)擴建噴霧干燥能力的生動注腳。“這樣的例子還有很多，噴霧干燥技術(shù)在解決重大開發(fā)難題方面具有巨大潛力。”陳金玲博士語氣堅定。

攻堅分子溶解度，一項技術(shù)的深耕與進化

噴霧干燥技術(shù)并非新鮮事物，它在食品、化工領(lǐng)域早已有廣泛應(yīng)用。但在制藥領(lǐng)域，它肩負著特殊的使命：攻堅那些結(jié)構(gòu)越來越復雜、溶解度越來越差的“難開發(fā)分子”。

正如陳金玲博士所言：“許多小分子化合物，尤其那些分子量更大、結(jié)構(gòu)更復雜的分子，在藥物開發(fā)中最常見的挑戰(zhàn)之一是溶解度和吸收率低。”隨著科學的進步，藥物研發(fā)的邊界被不斷推向前沿。過去幾十年，相對簡單的分子如同“樹上低垂的果實”已被摘完，現(xiàn)在科學家們面對的，是那些更高處、更難以觸及的目標。

“我們正不斷進入前人未曾涉足的領(lǐng)域，去摘取那些更高處的果實。這自然帶來了更復雜的分子結(jié)構(gòu)。”陳金玲博士分析道，“隨著科學的進步，我們對藥物靶點的理解更深入了，有機化學家們也掌握了構(gòu)建復雜分子的先進工具。一些過去因成本或技術(shù)限制而無法實現(xiàn)的想法，如今借助現(xiàn)代科技也變得可行。”

無論是靶向KRAS這類“難以成藥”靶點的抗腫瘤藥，還是其他具高分子量的復雜分子結(jié)構(gòu)，都預(yù)示著新藥開發(fā)領(lǐng)域正面臨一個共同的趨勢：分子結(jié)構(gòu)的復雜化。

“分子結(jié)構(gòu)正變得越來越復雜，合成路線更長，官能團更多，這使得化合物的溶解和吸收愈發(fā)困難。”陳金玲博士指出，若不解決這個瓶頸，即使分子的靶向性再精準、藥理活性再強，如果無法被人體有效吸收，將無法用于口服制劑。

目前，難溶化合物的挑戰(zhàn)是全球性的，整個行業(yè)都在探索各種創(chuàng)新技術(shù)來應(yīng)對這一趨勢。藥明康德旗下的合全藥業(yè)多年來打造了包括噴霧干燥分散、熱熔擠出、納米懸浮、液體膠囊等全方位的工藝技術(shù)平臺。而噴霧干燥分散技術(shù)是經(jīng)驗證極為有效的解決方案之一。

作為全球創(chuàng)新的賦能者，藥明康德多年來已逐步構(gòu)建起完整的噴霧干燥分散技術(shù)能力與配套設(shè)備，可支持從實驗室規(guī)模到臨床及商業(yè)化生產(chǎn)的開發(fā)與生產(chǎn)。目前，合全藥業(yè)已配備各種規(guī)模的噴霧干燥設(shè)施（如PSD-1、PSD-3和PSD-4），可靈活應(yīng)對不同階段分子的需求。

“實驗室階段，我們使用小型噴霧干燥機來評估化合物的特性，并在早期開發(fā)階段支持化合物篩選。隨著項目推進，我們會切換至符合GMP標準的設(shè)備來生產(chǎn)臨床試驗用藥物。商業(yè)化生產(chǎn)階段，則啟用如PSD-4這般大型噴霧干燥設(shè)備。”陳金玲博士進一步介紹道。

而且，這種從實驗室微量研究到商業(yè)化生產(chǎn)的完整配套能力，并非孤立的點，而是一張覆蓋全球的網(wǎng)絡(luò)。“不僅是庫威，在泰興我們也配備了完全相同的PSD-4噴霧干燥設(shè)施，實現(xiàn)了從毫克級研發(fā)到大規(guī)模生產(chǎn)的全覆蓋。”這種雙基地平臺布局，不僅確保了工藝的穩(wěn)健性和質(zhì)量的一致性，更構(gòu)建了穩(wěn)定可靠的全球供應(yīng)體系。

在賦能客戶的眾多案例中，噴霧干燥技術(shù)的一體化平臺優(yōu)勢被一次次驗證。

幾年前，合全藥業(yè)曾參與開發(fā)的一款糖尿病藥物，團隊運用噴霧干燥技術(shù)，成功開發(fā)出了片劑制劑。該藥現(xiàn)已成功上市，惠及了眾多患者。截至目前，合全藥業(yè)噴霧干燥技術(shù)平臺已支持5款新藥成功獲批上市。

“無論是助力腫瘤學領(lǐng)域KRAS靶向藥或靶向蛋白降解劑開發(fā)，還是助力糖尿病領(lǐng)域新藥的制劑開發(fā)，這些例子都凸顯了公司在這些重大疾病領(lǐng)域?qū)蛻舻膱远ㄖС忠约皩π袠I(yè)的持續(xù)貢獻。”陳金玲博士充滿自豪。

超越技術(shù)的邊界：CRDMO的“交響樂”

如果說噴霧干燥等技術(shù)是一門獨奏樂器，那么藥明康德的一體化CRDMO平臺，就是一整支交響樂團。

一款抗癌藥的開發(fā)歷程案例可以有力證明這一點。在項目早期臨床階段，客戶便將整個項目托付給藥明康德旗下的合全藥業(yè)。這不僅僅是一個噴霧干燥的委托，而是涵蓋了從原料藥、中間體、固體分散體到制劑的全鏈條研發(fā)與生產(chǎn)，甚至包括了后續(xù)的注冊、驗證及動態(tài)核查等復雜環(huán)節(jié)。

想象一下這個場景：在藥明康德的某個基地，剛剛合成出幾十克的原料藥后，立即運至另一個基地，噴霧干燥團隊在收到樣品的第一時間啟動制程，制備出固體分散體（Spray-Dried Dispersion，SDD）；而首批SDD樣品剛剛出爐，第三個基地的制劑團隊已做好接力準備——三地多團隊高效協(xié)同，確保項目流暢推進。

在不到兩年半的時間里，該項目順利完成。很快，客戶的這款抗癌藥物成功獲批上市。

“快”的背后，更深層的價值是“穩(wěn)”。多個任務(wù)在統(tǒng)一的質(zhì)量體系下平行推進，無縫銜接。一旦某環(huán)節(jié)需要強化、改進，所有團隊都能迅速響應(yīng)，這種即時的、跨部門的協(xié)同，能最大限度避免無效產(chǎn)出的產(chǎn)生，有效控制研發(fā)風險。

這些，正是藥明康德一體化賦能平臺與全球網(wǎng)絡(luò)的價值和精髓所在。其中，瑞士庫威基地作為這一網(wǎng)絡(luò)中的歐洲樞紐，也扮演著獨特而關(guān)鍵的角色。

“作為公司全球網(wǎng)絡(luò)的重要組成部分，庫威基地與各基地及平臺緊密協(xié)同，為客戶創(chuàng)造價值。無論是高效的項目推進、多元化的賦能技術(shù)平臺，還是全球團隊所具備的專業(yè)能力與豐富經(jīng)驗，客戶都能切實受益。比如在一次合作中，庫威與上海外高橋、無錫基地團隊緊密合作，短短5個月內(nèi)完成技術(shù)轉(zhuǎn)移及生產(chǎn)等，助力客戶順利遞交新藥申請（NDA）。”陳金玲博士表示。

在瑞士庫威基地，精良設(shè)備設(shè)施與設(shè)計理念之上，更融合了藥明康德自身的運營理念與質(zhì)量標準。“來訪客戶常將其描述為一座極具未來感、近乎理想化的生產(chǎn)基地。”陳金玲博士感慨，“憑借地處歐洲中心的地理優(yōu)勢，庫威基地作為全球網(wǎng)絡(luò)的一部分，能夠為客戶帶來高質(zhì)量、高效率、高度一體化的優(yōu)勢和價值。”

在這座充滿生命力的平臺上，來自客戶的每一個被嚴謹對待的分子，都承載著推動疾病治療的可能。這正是藥明康德“讓天下沒有難做的藥，難治的病”這一愿景在此處最切實的體現(xiàn)。

全球新藥研發(fā)面臨的挑戰(zhàn)依然復雜而艱巨，但藥明康德已做好準備，迎接挑戰(zhàn)，回應(yīng)客戶需求，向更高、更深處探索。這也正是藥明康德全球一體化CRDMO平臺始終秉持的初心與承諾：讓每一個有潛力的分子、每一位滿懷期待的客戶、每一位等待希望的患者，都不被辜負。

How WuXi AppTec Spray Drying Capabilities Solve the Complex Molecule Solubility Challenge | A Conversation with Dr. Jinling Chen

On May 6, 2026, WuXi AppTec welcomed customers and partners from around the world to its site in Couvet, Switzerland. At this facility in the heart of Europe, guests toured the highly automated drug product manufacturing lines, but the main attraction was a new piece of equipment—the PSD-4 spray drying system.

Dr. Jinling Chen, Senior Vice President and Head of Pharmaceutical Development and Manufacturing at WuXi AppTec, was on-hand to introduce guests to the newly completed spray drying plant. The new PSD-4 system is set to begin operations in the fourth quarter of this year.

To fully appreciate the ongoing investment in the spray drying capabilities at the Couvet site, it’s important to have insight into some history.

A few years ago, WuXi AppTec took on a complex new drug development project involving a molecule with a molecular weight of over 1000 Daltons, poor water solubility, and an oral absorption rate of less than 1%. It was almost written off as "non-viable for development."

Across the industry, such molecules, specifically Proteolysis Targeting Chimeras, represent a frontier in cancer drug R&D, offering significant advantages in targeting proteins once considered "undruggable." However, their high molecular weight and complex chemical structure posed enormous development challenges—poor aqueous solubility and low oral bioavailability.

When the client approached WuXi AppTec, Dr. Chen and her team did not give up easily. "Through close collaboration with the client, the team explored various drug delivery methods to improve the compound's bioavailability, ultimately finding spray drying to be most effective," she recalled.After careful spray drying and formulation screening, optimization, and process optimization, the team successfully increased the compound's bioavailability to over 30%, rendering it viable for further clinical development.

This 30% figure is more than just a data point in a lab. It meant that a compound destined for the shelf — a molecule that had been "nearly abandoned" earned a new ticket to continue into clinical development and, ultimately, to reach patients.

This is just one example of how spray drying can solve significant development challenges. It is a story that vividly underscores WuXi AppTec’s ongoing enhancement of spray drying capabilities. "There are many such examples. Spray drying technology holds immense potential for addressing major development challenges," Dr. Chen stated.

Tackling Molecule Solubility: The In-Depth Evolution of a Technology

Spray drying is not a new concept; it has been widely used in food and chemical industries for decades. In the pharmaceutical sector, it serves a unique purpose: tackling the "hard-to-develop molecules" whose structures are becoming increasingly complex and whose solubility is declining.

As Dr. Chen explained, “For many small molecules, especially those with larger molecular weights and complex structures, one of the most common challenges in pharmaceutical development today is poor aqueous solubility and low oral absorption rates, known as BCS Class II or IV compounds.” With scientific advancements, the boundaries of drug development are constantly being pushed. Over the past few decades, relatively simple molecules—the low-hanging fruit—have already been picked, leaving scientists to focus on tackling more complex molecules.

"We are entering more untouched territories, leading to more complex molecules," Dr. Chen continued, "With advancements in science, we understand more about targets, and organic chemists have better tools to form these complex molecules. Additionally, what was once economically unviable is now possible with modern technology."

Whether it’s anti-tumor drugs targeting “undruggable” KRAS proteins or other complex molecules with high molecular weight, the field of new drug development is facing a common trend: increasing molecular weight and complexity.

"Molecules are becoming more complex, with longer synthetic routes and more functional groups, making them harder to dissolve and absorb," Dr. Chen pointed out. "If this bottleneck is not addressed, even with precise targeting and potent pharmacological activity, molecules cannot be developed into oral formulations if they cannot be effectively absorbed by the human body."

The challenges are the same globally, and the entire industry is exploring innovative technologies to address them.WuXi AppTec’s subsidiary, STA, has spent years building a comprehensive drug delivery technology platform, including Spray Drying (SDD), Hot Melt Extrusion, Nano Particles, and Liquid Capsules. Among these, spray drying has proven to be one of the most effective solutions.

"Spray drying technology has been an essential tool to address these challenges.” Dr. Chen remarked.

As a global enabler of innovation, WuXi AppTec has, over the years, built a complete set of spray drying and supporting equipment, enabling development and manufacturing from lab scale to clinical and commercial production. Currently, STA possesses different types of spray drying systems (such as PSD-1, PSD-3, and PSD-4), offering the flexibility to meet the needs of molecules at different stages.

“In the lab, we use small-scale spray dryers to evaluate compound properties and support formulation selection during the early development stages. As the compound progresses, we scale up to GMP-compliant spray dryers to produce clinical trial materials. For commercial production, we use large-scale spray dryers like the PSD-4, which is a six-story tall piece of equipment,” Dr. Chen further explained.

Furthermore, this complete capability—from small-scale production to commercial manufacturing—is enhanced by a broad, global network. “Not only in Couvet, but also our site in Taixing, is equipped with identical PSD-4 equipment.” This dual-site strategy ensures process robustness, quality consistency, a stable and reliable global supply network.

The advantages of this integrated spray drying technology platform have been repeatedly validated in numerous customer projects.

A few years ago, Dr. Chen’s team was involved in the development of a diabetes drug for a client. Using spray drying, the team successfully developed a tablet formulation that is now available in the market, benefiting many patients. To date, STA's spray drying platform has facilitated the successful approval and launch of five commercial new drugs.

“Whether assisting in the development of KRAS-targeted drugs in oncology or aiding the formulation development of new diabetes drugs, these examples highlight our firm support for clients in these critical disease areas and our ongoing contribution to the industry,” Dr. Chen said.

Beyond Technical Boundaries: The Symphony of the CRDMO Platform

If technologies like spray drying are akin to playing a solo instrument, then WuXi AppTec’s integrated CRDMO (Contract Research, Development, and Manufacturing Organization) platform represents a full symphony orchestra.

A case study in the development of an anti-cancer drug clearly illustrates this point. In the early clinical stages, the client entrusted the entire program to STA. This wasn’t merely a spray drying contract; it encompassed the full spectrum of development and manufacturing, from the active pharmaceutical ingredient (API), intermediates, and solid dispersions to the final drug product, including the subsequent stages of registration, validation, and regulatory inspection.

Imagine this scenario: At one of WuXi AppTec’s sites, after synthesizing just a few grams of the API, it was immediately transported to another site where the spray drying team started working on the process, preparing solid dispersions. Meanwhile, as the first batch of SDD samples was ready, the formulation team at a third site was prepared to take over — multiple teams across three locations working efficiently in parallel to ensure the project progressed smoothly.

In less than two and a half years, the CMC development and clinical studies were successfully completed. Soon after, the client’s anti-cancer drug was approved and launched.

Behind the speed, the deeper value lies in robustness. Multiple tasks progress simultaneously within a unified quality system, seamlessly connected. Whenever a process step needs improvement, all teams can quickly respond, ensuring real-time cross-department collaboration. This kind of seamless, cross-departmental collaboration minimizes the risk of ineffective output and effectively controls development risks.

This exemplifies the value and essence of WuXi AppTec’s integrated CRDMO enabling platform and its global network. Within this network, the Couvet site in Switzerland plays a unique and crucial role as the European hub.

"As an integrated part of our organization, the Couvet site, along with our facilities globally, provides significant value to our customers. They benefit from our speed, diversified enabling technologies, and the expertise and capabilities of our team around the world. As an example, teams in Shanghai, Wuxi City, and Couvet collaborated closely, rapidly aligning the tech transfer from China to Couvet and advanced the project to NDA submission in just 5 months." Dr. Chen explained.

At the Couvet site, advanced equipment and design concepts are complemented by WuXi AppTec’s operational philosophy and quality standards. "Clients who visit often describe it as a futuristic, dream facility for pharmaceutical manufacturing," Dr. Chen reflected. Leveraging its central European location, the Couvet site, as part of the global network, brings clients the advantages and value of high quality, high efficiency, and high reliability.

Every molecule that is handled with meticulous care holds the potential to advance disease treatment. And while the challenges of global new drug development remain complex, WuXi AppTec is prepared to address the challenge to fulfill the vision that "Every drug can be made, and every disease can be treated."

免責聲明：本文僅作信息交流之目的，文中觀點不代表藥明康德立場，亦不代表藥明康德支持或反對文中觀點。本文也不是治療方案推薦。如需獲得治療方案指導，請前往正規(guī)醫(yī)院就診。

版權(quán)說明：歡迎個人轉(zhuǎn)發(fā)至朋友圈，謝絕媒體或機構(gòu)未經(jīng)授權(quán)以任何形式轉(zhuǎn)載至其他平臺。轉(zhuǎn)載授權(quán)請在「藥明康德」微信公眾號回復“轉(zhuǎn)載”，獲取轉(zhuǎn)載須知。